Phase2a Primaquine Dose Escalation Study

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 2

Conditions: Malaria

Treatments: Drug: 0.25 mg/kg Primaquine; Drug: 0.125 mg/kg Primaquine; Drug: 0.0625 mg/kg Primaquine; Drug: 0.5 mg/kg Primaquine; Drug: dihydroartemisinin-piperaquine

Study type: Interventional

Funder types: Other

Identifiers

NCT01743820

MEG001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low single-dose primaquine for gametocidal activity against P.falciparum among adult glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.

Enrollment: 81 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Male
• Age >= 18 years and < 50 years
• Malaria blood thick film positive
• Presence of gametocytes on thick blood film
• Agrees to admission to study ward for 26 hours post diagnosis and available for follow up visits
• No allergies to study drugs
• Hemoglobin >= 8 g/dl
• No evidence of severe or chronic disease
• Written, informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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81 participants in 5 patient groups

dihydroartemisinin-piperaquine only

Active Comparator group

Description:

dihydroartemisinin -piperaquine (DP) only

Treatment:

Drug: dihydroartemisinin-piperaquine

DP and 0.125 mg/kg primaquine

Experimental group

Description:

DP and single dose oral 0.125 mg/kg primaquine

Treatment:

Drug: 0.125 mg/kg Primaquine

Drug: dihydroartemisinin-piperaquine

DP and 0.5 mg/kg primaquine

Experimental group

Description:

DP and single dose oral 0.5 mg/kg primaquine

Treatment:

Drug: dihydroartemisinin-piperaquine

Drug: 0.5 mg/kg Primaquine

DP and 0.25 mg/kg primaquine

Experimental group

Description:

DP and a single dose oral 0.25 mg/kg primaquine

Treatment:

Drug: 0.25 mg/kg Primaquine

Drug: dihydroartemisinin-piperaquine

DP and 0.0625 mg/kg primaquine

Experimental group

Description:

DP and a single dose oral 0.0625 mg/kg primaquine

Treatment:

Drug: 0.0625 mg/kg Primaquine

Drug: dihydroartemisinin-piperaquine